Comparison of Next Generation Laser Techniques of Myopia Correction: iDesign vs. SMILE

December 19, 2016 updated by: Dr Rohit Shetty, Narayana Nethralaya
The proposed study seeks to compare visual acuity, tomographic outcomes, biomechanical changes and inflammatory profile of normal eyes (matched for age, refraction and corneal thickness) undergoing iDesign and SMILE procedure. The hypothesis is that iDesign may deliver equivalent or better clinical outcomes than SMILE, by removing less tissue and correcting for higher order aberrations.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

iDesign is a promising new technique to treat myopia with astigmatism using ocular aberrations measured with a high resolution wavefront sensor.[1,2] Early studies with iDesign platform has established its safety and efficacy in correction of myopia with fewer patients reporting night vision problems.[1,2] In keratoconus, iDesign has also provided excellent outcomes following collagen crosslinking.3 SMILE is a recent technique that eliminates creation of flap and appears to achieve similar refractive outcomes as conventional LASIK but with less dryness, less inflammation and faster wound healing.[4,5] SMILE corrects lower order aberrations only.[4,5] Thus, a comparative assessment of iDesign and SMILE is necessary since iDesign can potentially give better visual outcomes with lower volume of tissue removal. If lower volume of tissue is removed, it is also hypothesized that the corneal would be more stable biomechanically.[5] Further, SMILE does not provide any correction of higher order aberrations. With the inclusion of higher order aberrations in the iDesign treatment plan, it is hypothesized that both short and long term outcomes will be better with iDesign than with SMILE.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560010
        • Recruiting
        • Narayana Nethralaya
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients should be between 18 to 50 years of age.
  2. Patient must have stable myopia for a minimum period of one year (a change of 0.25D or less) as documented by prior clinical records or current spectacle correction.
  3. Patient must have a corrected distance visual acuity (CDVA) of 20/25 or better,
  4. Patient must have a spherical equivalent refraction less than -10D
  5. Patient must have refractive astigmatism less than 3D.

Exclusion Criteria:

  1. Patient must not have a central corneal thickness (CCT) less than 480 micrometer
  2. Patient must not have a calculated residual stromal bed thickness of less than 250 micrometer after the surgery
  3. Patient must not have symptoms or signs of keratoconus, diabetes, collagen vascular disease, pregnancy, breastfeeding and any prior ocular surgery.
  4. Patient must not have an inter-ocular difference of more than 1.00 diopter (D) of spherical or 0.50 D of cylindrical refractive error.
  5. Patient must not be on chronic systemic steroids or other medication that can affect wound healing.
  6. Patient must not be allergic to primary or alternative medications.
  7. Patient must not be using rigid contact lenses for the last three weeks or soft contact lenses for at least 1 week before the preoperative evaluation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: iDesign
Eyes will under LASIK using iDesign platform for treatment of sphere and cylinder power
Other: iDesign
One group will under go standard LASIK using iDesign platform (J&J, USA). Visual acuity, tomography outcomes, biomechanical outcomes and inflammation in myopic eyes treated with iDesign and SMILE are proposed to be evaluated under the study.
ACTIVE_COMPARATOR: SMILE
Eyes will under SMILE using Visumax platform for treatment of sphere and cylinder power
Other: SMILE
The other group will undergo SMILE for treatment refractive error (Carl Zeiss, Germany). isual acuity, tomography outcomes, biomechanical outcomes and inflammation in myopic eyes treated with iDesign and SMILE are proposed to be evaluated under the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in visual acuity measured as Logarithm of manifest refraction
Time Frame: Post surgery over a period of 1 year
Uncorrected and corrected distance visual acuity
Post surgery over a period of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Corneal curvature in Diopter
Time Frame: Post surgery over a period of 1 year
Optical coherence tomography and Scheimpflug imaging of the cornea will be performed
Post surgery over a period of 1 year
Change in deformation of the cornea
Time Frame: Post surgery over a period of 1 year
Air-puff applanation of the cornea will be used to asses deformation
Post surgery over a period of 1 year
Change in ocular surface dryness and/or pain
Time Frame: Post surgery over a period of 1 year
Assessed by ocular surface discomfort score
Post surgery over a period of 1 year
Change in wavefront aberrations described by Zernike Polynomials
Time Frame: Post surgery over a period of 1 year
Corneal and ocular aberrations
Post surgery over a period of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Narayana Nethralaya

Investigators

  • Principal Investigator: Rohit Shetty, MD, PHD, Narayana Nethralaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria

December 19, 2016

First Posted (ESTIMATE)

December 23, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 23, 2016

Last Update Submitted That Met QC Criteria

December 19, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C/2016/09/07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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